FDAnews
Falls Church, VA (PRWEB) February 20, 2015
Conducting Internal GMP/QSR/GCP/GLP Investigations:
How to Avoid Sleepless Nights, Irreparable Harm to Your Company’s Reputation, and Massive Civil and Criminal Liability
**Presented by FDAnews and Alston & Bird LLC **
April 22-23, 2015 – Washington, DC
http://www.fdanews.com/ConductingInternalInvestigations
Don’t think a GMP/QSR/GCP/GLP whistleblower could bring a manufacturer down? Think again. One recent case resulted in penalties totaling $846 million. Here’s how to protect a drug or device manufacturing, laboratory or clinical operation.
Come to Washington for a two-day crash course in how to conduct internal investigations related to possible GMP, QSR, GCP or GLP data integrity and whistleblower related violations. Attendees will come home toting a bagful of tricks and tips to improve internal processes, strengthen compliance systems and avoid lawsuits.
Taught by three accomplished clinical, manufacturing, laboratory and white-collar crime attorneys — who have more than 50 years of experience conducting investigations, this event is like no other on the market. Get ready to discover:
How to assess initial allegation(s)
While each investigation is unique, attendees will learn guidelines that help them respond swiftly and appropriately to whistleblower complaints.
Practical and actionable first steps
- Identifying scope and purpose of the investigation
- Structuring the investigative team of internal employees, outside counsel and subject-matter experts
- Maintaining credibility of the investigation and protecting attorney-client privilege
- Best practices in document preservation and review, done cost-effectively but ready to withstand regulators’ tightest scrutiny
- Tips on interviewing employees drawn from 50 years of collective experience and hundreds of actual interviews
The ‘Park Doctrine’
Prosecutions under the so-called “Park Doctrine” are a growing threat. The “Park Doctrine” mirrors a recent Justice Dept. policy shift to changing corporate misbehavior by holding officers and employees individually accountable.
Changing corporate culture
Attendees will learn all about the “responsible corporate officer,” how one can be held liable for violations of the FDCA with no criminal intent, and how to avoid such prosecutions by cultivating a corporate culture that puts quality first.
Homeward bound
As the workshop winds up, attendees will come away with a deepened understanding of how to conduct internal investigations, plus mitigation strategies to avoid the sort of GMP/QSR/GCP/GLP that have cost others millions of dollars in civil — and criminal — penalties.
Course materials include:
- Copies of all presentations
- Current FDA regulations (full text unedited)
- Tips on conducting internal investigations
- Guidances
- Case studies
- Checklists
- Sample litigation hold/preservation notice
- Employee and witness interviewing do’s and don’ts
- Article: “Recurring Issues in Internal Investigations”
- Article: “How the Justice Dept. Consumer Protection Branch Conducts Criminal Investigations of the FDCA”
- Article: “How the Justice Dept. Uses the ‘Park Doctrine’ to Hold Officers, Managers and Employees Criminally Liable for Violations of the FDCA – No Criminal Intent Required”
Meet the Instructors:
Cathy Burgess is a partner in Alston & Bird’s Health Care Group focusing on FDA matters. Ms. Burgess advises clients on matters affecting Rx and OTC drugs, biologics, medical devices, foods and cosmetics, working with clients to spot legal risks throughout product life cycles. With her cGMP expertise, she focuses on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Forms 483 and Warning Letters. She also conducts internal investigations and special audits related to FDA compliance, and helps clients design compliance programs, internal audit programs and other risk mitigation strategies.
Edward (Ted) Kang is a partner in Alston & Bird’s Government & Internal Investigations Group. He focuses on white collar matters in the areas of health care, anti-corruption, Office of Foreign Assets Control (OFAC) sanctions, anti-money laundering, and the Foreign Corrupt Practices Act (FCPA). Clients include parties under investigation by the Justice Dept. and other federal and state enforcement agencies.
Mark Calloway, is a partner and immediate past leader of Alston & Bird’s Government & Internal Investigations Group, specializes in white collar criminal defense with an emphasis on health care, internal corporate investigations, compliance program development, implementation and auditing.
Conference Details
Conducting Internal GMP/QSR/GCP/GLP Investigations:
How to Avoid Sleepless Nights, Irreparable Harm to Your Company’s Reputation, and Massive Civil and Criminal Liability
**Presented by FDAnews and Alston & Bird LLC **
April 22-23, 2015 – Washington, DC
http://www.fdanews.com/ConductingInternalInvestigations
Tuition: $1,897
Easy Ways to Register
Online: http://www.fdanews.com/ConductingInternalInvestigations
By phone: 888-838-5578 or 703-538-7600
About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
